Life is experienced, when you step out of your comfort zone. I made a choice over 13 years ago to do exactly that (in the hope of making a positive change to the network). Transitioning from studying Pharmacology to writing dossiers and launching medicinal products on the market provided the foundations for my next move. The sideways step into technology was met with nervous excitement and a world full of acronyms (what is eCTD and PIM?). Very early on I joined Telematics meetings with the EMA and NCA, questioning why I am here? I was inspired by how people spoke passionately about the future but left confused how everything connected together.
Upon reflection of my early years, I soon realised I didn’t really understand where we were going? My curiosity set in and it was time to really get involved.
The EMA and HMA have a joint telematics organisation, known as the EU Telematics Management Board.
The taskforces and working groups are working at an operational level, feeding information at strategic level. You can find more inormation here.
Over the years, my ability to understand how the telematics ecosystem functioned, provided me great advantages. As a member of Medicines for EU, I was nominated to be involved within the eCTD and xEVMPD working groups, which at the time were run like projects, with fixed face to face meetings where the EMA and NCA would share presentations of what had been achieved and a status of what was happening. As an observation I quickly realised the emphasis on the operational deliverables, which could cause challenges to deliver a solution that met visionary goals and taking into consideration the ongoing projects within the network.
To go fast, go alone - to go far, go together
Imagine what could be achieved and then go deliver it, there were guiding principles that were crucial to keep us on the track to success
- Invest in a strong regulatory network, by leveraging technology, this will support connecting to e-Health
- Optimise the regulatory submission process by improving the regulatory assessment and decision making
- Pan-EU collaboration to ensure efficient access to information
- Standardised Global Governance, transition towards structured data that has the opportunity to communicate globally
- Continue to scan the horizon for future opportunities and challenges
When writing dossiers, technology was something that I just needed to work with, it should work and not be seen. I transitioned to ISO IDMP taskforce with an uneasy feeling, instincts kept saying “here we go again” but the vision was lost, and collaboration had room for improvement. I was lucky enough to be working with some amazing people who knew what was important, we had spoken about it many times. Maybe this time it would be different, maybe I could step away? I decided to go on a travel sabbatical for 5 months, optimistic that once I was back, IDMP would be implemented and we could talk about all those other benefits that could be addressed.
Fast forward 7 years, we are where we are. The vision is a lot clearer than it was all those years ago, we reached our first milestone of the EU IG v2.0 being released.
The EMA created dedicated focus groups, comprising of 10 industry colleagues. It was our responsibility to check the results of public consultations of the initial draft implementation guide, as well as looking at the business processes. We worked closely with NCA and EMA representatives to produce a guide that would act as a foundation for the implementation of ISO IDMP in Europe.
We split ourselves into further groups to overcome topics such as how identifiers would work from a technical and business point of view. We continued to open up communication with other experts from other programmes (such as Falsified Medicines) to understand their requirements to ensure the data that was collected worked for the entire network, based on the objective to be achieve. This type of work required the ability to deep dive into the details while maintaining an objective overview of everything.
Another topic was to focus on how the submission process would need to be designed, in order for the eCTD and PMS data to have a relationship, which relied on the granularity of identifiers and how the PMS identifiers connect to the eCTD UUID. In order to come up with a solution that could work (still to be tested), it was important to look at what is submitted in an initial MAA and deep dive into the metadata of a submission.
I drew experience from years of lessons learn, my role in Product Management requires me to know what the stakeholders need to reach their objectives. I also have to understand the details of a requirement so I can explain to the technical teams for possible solutions. The goal for Product Management is to deliver value to our stakeholders while navigating people to a better future.
To many of us, the identifiers were not just random unique numbers to be consumed by a master data system but the building blocks to connect the network and the patients/health care professional, if implemented correctly they would continue to add value for decades to come
Working with EXTEDO has been an eye opener, I am able to work for an organisation that provides software to over 35 global health authorities, it is great to be able to share experiences and best practises so that they can save time while creating efficient ways to assess and make decision on life changing medicinal product authorisations. I am proud to be able to support industry and agency to drive efficiency and value.
The ISO IDMP implementation within Europe has been released in a stepwise approach, in our webinar, we talk about what is new and how your submission management process wil change in the near process. Watch the recording of our webinar: "Discover the mystery around IDMP - what's new in the EU IG v2.0".